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Completed

NCT Number: NCT03552991

Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the effect of a commercial dietary fiber supplement on patients with type 2 diabetes mellitus, in the way of glucose control, insulin action in the body, and the gut microbiota (bacteria) abundance.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Fiber supplements such as psyllium are known to be beneficial to glycemic control in patients with type 2 diabetes mellitus (T2DM). Gut microbiota has a role in regulating host energy metabolism and systemic inflammation by several pathways such as short-chain fatty acid production, fasting-induced adipose factor expression, endocannabinoid system, and gut epithelial permeability. As dietary components can influence the composition of the microbiota, we hypothesized that fiber supplements could modify gut microbiota and consequently affect glycemic control and inflammatory condition in patients with T2DM.

The primary outcome was to assess the effect of fiber on glucose control (by comparing fasting glucose and glycoalbumin), insulin secretion and sensitivity. Secondary outcomes were the changes abundance of microbiota, incretins, and lipopolysaccharide (LPS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all of the followings):

  • Among type 2 diabetic patients who visit Diabetes Center at Samsung Medical Center
  • 2 or more of following are required:
  • use of lipid-lowering drugs and / or triglyceride ≥ 150 mg/dL, high-density lipoprotein < 40 mg/dL in men and < 50 mg/dL in women
  • waist circumference > 90 cm in men and > 80 cm in women
  • antihypertensive medication and / or blood pressure ≥ 130/85 mmHg
  • Hemoglobin A1c level 7.0 - 9.0% (6.5 - 9.0% in age 50-60 years old)
  • Patients who are treated with combination therapy of sulfonylurea and metformin at least 6 months and in steady-glucose-controlled state.

Exclusion criteria

(at least one of the followings):

  • Patients using insulin, alpha-glucosidase inhibitor, meglitinide, thiazolidinedione, or incretin agent (both oral or injectables)
  • Recently diagnosed (within 6 months) acute diabetic complication such as diabetic ketoacidosis and hyperosmolar hyperglycemic state
  • Clinically significant cardiovascular disease
  • Patients treated with oral or intravenous antibiotics last 12 months
  • Patients who took fiber supplements last 6 months
  • Fasting serum c-peptide level < 1 ng/mL
  • Duration of type 2 diabetes > 10 years

Treatment and study plan

Agiocur Pregranules

Drug

6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout

Other names: Agio gran.

Primary outcomes

  1. Fasting glucose

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  2. Glycoalbumin

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  3. Insulinogenic index

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  4. Quantitative insulin sensitivity check index (QUICKI)

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline. QUICKI is derived from fasting blood glucose and insulin level, reflecting insulin sensitivity.

Secondary outcomes

  1. Microbiota composition change

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  2. Incretins (GIP)

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  3. Incretins (GLP-1)

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  4. Incretins (GLP-2)

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

  5. Lipopolysaccharide (LPS)

    Time frame: the 4th week of study

    By comparing the level of 4th week, compared to baseline

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Bukwang Pharmaceutical, Co., Ltd.
  • ChunLab, Inc.

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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